MAUDE Adverse Event Report: EXACTECH, INC. PS TIBIAL INSERTS SZ 2, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	204-22-11
Medical Device Problem Codes	Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Discomfort (2330); Ambulation or Postural Difficulties (2544); Balance Problems (4401); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/03/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
It was reported by the legal department that this female patient's ps knee was revised 5 years post op initial surgery.Revision was to change the patella and add a thicker insert.
Additional Manufacturer Narrative
Additional information: a4, & b7 there is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No additional information is available.H6.Investigation -based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the subsequent revision cannot be conclusively determined, insufficient information.These devices are used for treatment not diagnosis.
Event or Problem Description
It was reported via legal documentation that a patient had a right knee arthroplasty and then experienced a revision surgical procedure approximately 4 years, 8 months after initial implant for the tibial insert component.The patient experienced daily pain and discomfort in her right knee, which has limited her activities of daily living and impacted her qualify of life.Patient has suffered debilitating injuries and damages, including but not limited to, pain and discomfort; swelling; gait impairment; poor balance; component part loosening; soft tissue damage; bone loss; bone damage; and other injuries presently undiagnosed, which all require ongoing medical care.There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
H10.Related: mfr#1038671-2024-02484 report 2 of 2.H11.Additional manufacturer narrative- additional information added.Report 1 of 2.D10.Concomitants: 200-02-32 - three peg patella 32mm, 1226926.204-01-02 - ps cemented femoral sz 2, 8221698.204-04-22 - trapezoid tibial tray sz 1f/2t, 2f/2t, 1200696.These devices are used for treatment not diagnosis.There is no additional information available.Pending investigation.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were corrected: d1, h6 mdr section codes updated/corrected: b, e.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear and loosening or due to inclusion of the polyethylene in the packaging recall.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images, radiographs, and relevant clinical information were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: PS TIBIAL INSERTS SZ 2, 11MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 3523771140
• MDR Report Key: 16395758
• Report Number: 1038671-2023-00186
• Device Sequence Number: 17736184
• Product Code: JWH
• UDI-Device Identifier: 10885862048233
• UDI-Public: 10885862048233
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K933610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/27/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/15/2016
• Device Catalogue Number: 204-22-11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2023
• Supplement Date Received by Manufacturer: 04/21/2023; 07/18/2024; 01/24/2025
• Initial Report FDA Received Date: 02/17/2023
• Supplement Report FDA Received Date: 04/21/2023; 07/23/2024; 01/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2008
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 159 KG